Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00651300




Registration number
NCT00651300
Ethics application status
Date submitted
31/03/2008
Date registered
2/04/2008
Date last updated
11/06/2009

Titles & IDs
Public title
A Study of the Recovery Benefits After Treatment With Parecoxib/Valdecoxib in Patients Undergoing Abdominal Surgery
Scientific title
A Multicentre, Double-Blind, Placebo-Controlled Study of the Recovery Benefits Following Treatment With a Cox-2 Regimen in Patients Undergoing Elective Laparoscopic Intra-Peritoneal Abdominal Surgery
Secondary ID [1] 0 0
A3481026
Secondary ID [2] 0 0
PARA-0505-086
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Parecoxib/Valdecoxib
Treatment: Drugs - Placebo

Experimental: Group 1 -

Placebo Comparator: Group 2 -


Treatment: Drugs: Parecoxib/Valdecoxib
A single 40mg dose of intravenous (IV) parecoxib sodium administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of valdecoxib 40 mg (2 x 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3

Treatment: Drugs: Placebo
A single dose of IV saline (placebo) administered on Day 1 immediately before the surgical procedure as part of the Investigator's usual analgesic management practice, followed by oral doses of placebo (2 x matching valdecoxib 20 mg tablets) at 6-8 hours post-surgery on Day 1 and in the morning of Day 2 and Day 3
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total intake of morphine in first 4 hours post-surgery upon waking of patients receiving parecoxib versus control group.
Timepoint [1] 0 0
4 hours
Secondary outcome [1] 0 0
Evaluation of unplanned hospital admissions on Day 4.
Timepoint [1] 0 0
4 days
Secondary outcome [2] 0 0
Health Outcomes Recovery Questionnaire on Days 2, 3, and 4.
Timepoint [2] 0 0
4 days
Secondary outcome [3] 0 0
Collection of adverse events immediately before surgery, 1 and 6 hours after surgery, and on Days 2, 3, and 4.
Timepoint [3] 0 0
4 days
Secondary outcome [4] 0 0
Length of stay on Day 1.
Timepoint [4] 0 0
1 day
Secondary outcome [5] 0 0
Patient Satisfaction Questionnaire on Days 1 and 4.
Timepoint [5] 0 0
4 days
Secondary outcome [6] 0 0
Quality of Recovery Score on Days 1, 2, and 3.
Timepoint [6] 0 0
3 days
Secondary outcome [7] 0 0
Numerical Rating Scale on Days 1 (hourly for 6 hours), 2, 3, and 4.
Timepoint [7] 0 0
4 days
Secondary outcome [8] 0 0
Modified Brief Pain Inventory on Days 2, 3, and 4.
Timepoint [8] 0 0
4 days
Secondary outcome [9] 0 0
Readiness for discharge on Day 1.
Timepoint [9] 0 0
1 day

Eligibility
Key inclusion criteria
- Male or female aged 18 to 65 years weighing at least 50 kg but no more than 110 kg
undergoing elective intra-peritoneal laparoscopic abdominal surgery

- American Society of Anaesthesiologists (ASA) Physical Status I-III
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Significant chronic disease, such as renal, hepatic, cardiovascular, or respiratory,
which would contraindicate participation in the study or interfere with interpretation
of study results

- Active gastrointestinal disease, chronic or acute renal or hepatic disorder, or known
coagulation defect

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2004
Sample size
Target
Accrual to date
Final
91
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Port Macquarie
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Coopers Plain
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Townsville
Recruitment hospital [6] 0 0
Pfizer Investigational Site - Heidelberg
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Prahran
Recruitment hospital [8] 0 0
Pfizer Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
- Port Macquarie
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4108 - Coopers Plain
Recruitment postcode(s) [5] 0 0
4814 - Townsville
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
6847 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate morphine intake in the first 4 hours after abdominal
surgery. Morphine intake is compared between patients on placebo and patients on
parecoxib/valdecoxib.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00651300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00651300